生物学变异质量规范在干化学和常规化学检测系统间比对中的应用

The application of biological variation quality specifications to the comparison betweendry and conventional chemical detection systems

目的应用生物学变异质量规范评估不同参考区间的干化学和常规化学检测系统间的差异是否具有显著性。方法应用文献报道的参考改变值的公式转化为临床应用可接受的临界差异(CD)公式,再建立CD与个体内生物学变异和分析变异在不同检测系统下的关系,分别计算在95%和99%概率下的最优、期望、最低CD值。对17个常规生化检测项目在不同参考区间的干化学和常规化学检测系统上的相对偏差进行对比分析,以生物学变异质量规范的最优、期望、最低标准判断同一项目在2套检测系统间结果是否具有显著性差异或高度显著性差异。结果95%概率时有7个、99%概率时有13个项目达到最优质量规范,95%概率时有6个、99%概率时有4个项目达到期望质量规范,95%概率时有4个项目达到最低质量规范,在两套检测系统上17个常规生化项目检测结果无显著性差异或高度显著性差异。结论采用生物学变异质量规范模式评估不同参考区间的干化学和常规化学检测系统间的差异是否具有显著性的CD公式法具有简单易、操作性、针对性和实用性较强等特点,可为检验科工作人员提供一种不同检测系统间比对的评估方案。

Objective Biological variation quality specifications were applied to evaluate whether or not the differences between dry and conventional chemical detection systems at different reference intervals were significant.Methods The formula of the reference change value(RCV)reported in the literature was converted into the formula of acceptable critical difference(CD)for clinical application,Then the relationship between CD and individual endobiological variation(CVI)and analysis variation(CVA)under different detection systems was established,Calculate the optimal,expected,and lowest CD values with a 95%and 99%probability,respectively.The relative deviations of 17 conventional biochemical items in dry chemical and conventional chemical detection systems at different reference intervals were compared and analyzed to determine whether the results of the same item had significant or highly significant differences between the two test systems according to the optimal,expected and minimum standards of biological variation quality specifications.Results There was 7 items at the probability of 95%and a 99%chance that 13 items at the probability of 99%,which it met the optimal quality specification,There was 6 items at the probability of 95%and 4 items at the probability of 99%,which it met the desired quality specification,There was 4 items at the probability of 95%,which it met the minimum quality specification.There was no significant difference or highly significant difference in the test results of 17 conventional biochemical items on the two test systems.Conclusion Using the biological variation quality specification model to evaluate whether the difference between dry and conventional chemical testing systems at different reference intervals is significant,the CD formula method has the characteristics of simplicity,operability,pertinence and practicability,which can provide a kind of evaluation scheme for comparing different testing systems for laboratory staff.